Latest Headlines

Latest Headlines

German startup gets CE mark for first cardiac assist system to work with an existing heartbeat

Startup Xenios has zeroed in its platform of minimally invasive products to treat patients with heart and lung problems. Its latest addition is i-cor, a synchronized cardiac assist system that just received a CE mark for marketing in Europe. This makes it the first heartbeat-synchronized cardiac assist device for cardiogenic shock and high-risk interventions.

BioMarin's hopes in DMD fade after FDA panel pillories its case for approval

BioMarin's odds of winning FDA approval for a Duchenne muscular dystrophy treatment got longer on Tuesday after a group of agency advisers picked apart the company's clinical evidence and raised serious concerns about its safety.

FDA expands indication of Emergent BioSolutions anthrax vaccine

The FDA has expanded the indication of Emergent BioSolutions' BioThrax anthrax vaccine for use in adults aged 18 to 65 in conjunction with antibiotic treatment, following confirmed or suspected exposure to Bacillus anthracis.

Dr. Reddy's blasted in warning letter for hiding existence of testing lab from FDA

An FDA warning letter found that for years, Dr. Reddy's Laboratories was testing drug batches in a laboratory that the FDA was never told existed and often shipped to the U.S. products that had repeatedly failed tests for impurities.

Lilly's middling lung cancer drug wins FDA approval with a restrictive label

Eli Lilly won FDA approval for a lung cancer treatment that posted only a marginal survival benefit in late-stage clinical trials, gaining clearance to treat a small population of patients with particularly serious disease.

What if 21st Century Cures had been around before bapineuzumab blew up?

The so-called 21st Century Cures Act, now making its way through Congress, is designed to speed up the FDA review process for potentially lifesaving medicines by encouraging approvals based on midstage data. But a new case study takes a look at what might have happened if a trio of once-promising Alzheimer's drugs had made it to market before their eventual Phase III failures, painting a grim picture of the bill's potential.

Adapt Pharma earns FDA approval of first intranasal spray for emergency opioid overdose

Adapt Pharma's Narcan nasal spray became the first noninjectable treatment for opioid overdose emergencies thanks to its FDA approval on Nov. 19.

India's Biocon chief says R&D tax breaks essential for investment

As with most corporate chiefs, Biocon's normally would be pleased with India's proposal to lower the nation's corporate tax rate to 25% from 30%. But, if it means eliminating tax exemptions for investments in research and development, Biocon is opposed.

BMS racks up another Opdivo approval after FDA makes quick decision

Bristol-Myers Squibb has won yet another approval for its pioneering immuno-oncology drug Opdivo. The regulatory nod in advanced renal cell carcinoma, a form of kidney cancer, comes just one week after the FDA accepted the filing for priority review.

FDA approves BMS' Opdivo for kidney cancer a week after granting priority review

In another striking FDA turnaround for Bristol-Myers Squibb's Opdivo, the agency has approved it for treating advanced renal cell carcinoma just a week after granting priority review.